MetaSystems Probes has received IVDR certification for our XCyting FISH probes for prenatal aneusomy testing – the XA aneusomy probes.
Our Complete Set of XA Aneusomy Probes for Prenatal Testing Is IVDR Certified.
XL CRLF2 BA
Break Apart Probe
- Order Number
- D-5130-100-OG
- Package Size
- 100 µl (10 Tests)
- Regulatory Status
- IVDR
IVDR Certification
This probe is IVDR-certified in compliance with the Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). For organizational reasons, we currently provide only the IVDD product.
The XL CRLF2 BA break-apart probe is a qualitative, non-automated test for the detection of CRLF2-rearrangements at Xp22.33 and Yp11.32 by fluorescence in situ hybridization (FISH). The product is intended as a diagnostic aid and assists in disease monitoring. The test population consists of patients with confirmed or suspected acute lymphoblastic leukemia (ALL). Hybridization is to be performed on methanol/acetic-acid fixed cells derived from bone marrow or peripheral blood.
The XL CRLF2 BA break-apart probe consists of an orange-labeled probe hybridizing proximal to the CRLF2 gene region at Xp22.33 and Yp11.32 and a green-labeled probe hybridizing distal to the CRLF2 gene region at Xp22.33 and Yp11.32.
XL CRLF2 BA hybridized to bone marrow cells. Two aberrant cells of a patient with a gonosomal constellation of XXY are shown. Two normal CRLF2 loci were observed indicated by two fusion signals. The separate green signal indicates a deletion proximal of CRLF2.
Normal Cell:
Two green-orange colocalization/fusion signals (2GO).
Aberrant Cell (typical results):
One green-orange colocalization/fusion signal (1GO), one separate green (1G) and orange (1O) signal each resulting from a chromosome break in the respective locus.
Aberrant Cell (typical results):
One green-orange (1GO) colocalization/fusion signal and one green (1G) signal resulting from the loss of one orange signal.
IVDR Certification
MetaSystems Probes has received IVDR certification for our initial 26 fluorescence in situ hybridization (FISH) probes from the notified body, BSI. Achieving this milestone was not without its challenges, and we are delighted to have accomplished IVDR certification for this probe set at an early stage.
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